Surgical instrument for invagination and fundoplication

ABSTRACT

An endoscopic surgical instrument for deploying a two part fastener having a male fastener part and a female fastener part, includes a tube having a proximal end and a distal end. An end effector is coupled to said distal end of said tube and is configured to hold the male fastener part and the female fastener part in opposed relation. An actuator is coupled to said proximal end of said tube and is configured to actuate the end effector. A shearing device may be positioned proximate the end effector to shear off a tip of the male fastener part after the male and female fastener parts are moved into locking relation. In addition, the surgical instrument may include a male fastener part having a shaft with a plurality of detent positions. Further, the male fastener part may include a base and a shaft pivotally connected to the base.

CROSS REFERENCE TO RELATED DOCUMENTS

The present application is a continuation-in-part of U.S. patentapplication Ser. No. 09/572,974, filed May 18, 2000 now U.S. Pat. No.6,312,437, which is a continuation of U.S. patent application Ser. No.08/963,523 filed on Nov. 3, 1997, now U.S. Pat. No. 6,086,600. Theentire disclosure of both of these earlier applications is incorporatedby reference herein.

FIELD OF THE INVENTION

The invention relates to an endoscopic surgical instrument. Moreparticularly, the invention relates to a flexible instrument for thetransoral invagination and fundoplication of the stomach to theesophagus.

BACKGROUND OF THE INVENTION

Gastroesophageal fundoplication is a procedure for the treatment ofgastroesophageal reflux disease (GERD), a condition in which gastricacids are regurgitated into the esophagus resulting in esophagitis,intractable vomiting, asthma, and aspiration pneumonia. Thefundoplication procedure involves wrapping the fundus of the stomacharound the lower end of the esophagus and fastening it in place.Traditionally, this procedure is accomplished via open surgery with theuse of sutures to secure the plicated fundus of the stomach around theesophagus without penetrating (incising) the stomach.

U.S. Pat. No. 5,403,326 to Harrison et al. discloses a method ofperforming endoscopic fundoplication using surgical staples or two-partsurgical fasteners. The procedure disclosed by Harrison et al. involvesperforming two percutaneous endoscopic gastrotomies (incisions throughthe skin into the stomach) and the installation of two ports throughwhich a stapler, an endoscope, and an esophageal manipulator(invagination device) are inserted. Under view of the endoscope, theesophageal manipulator is used to pull the interior of the esophagusinto the stomach. When the esophagus is in position, with the fundus ofthe stomach plicated, the stapler is moved into position around thelower end of the esophagus and the plicated fundus is stapled to theesophagus. The process is repeated at different axial and rotarypositions until the desired fundoplication is achieved. While, theprocedure disclosed by Harrison et al. is a vast improvement over opensurgery, it is still relatively invasive requiring two incisions throughthe stomach. Moreover, the procedure requires the manipulation of twodifferent tools in order to position the fundus and to secure the fundusto the esophagus.

U.S. Pat. No. 5,571,116 to Bolanos et al. discloses a non-invasivetreatment of gastroesophageal reflux disease which utilizes a remotelyoperable invagination device and a remotely operable surgical stapler,both of which are inserted transorally through the esophagus. Accordingto the methods disclosed by Bolanos et al., the invagination device isinserted first and is used to clamp the gastroesophageal junction. Thedevice is then moved distally, pulling the clamped gastroesophagealjunction into the stomach, thereby invaginating the junction andinvoluting the surrounding fundic wall. The stapler is then insertedtransorally and delivered to the invaginated junction where it is usedto staple the fundic wall.

Bolanos et al. disclose several different invagination devices andseveral different staplers. Generally, each of the staplers disclosed byBolanos et al. has an elongate body and a spring biased anvil which isrotatable approximately 15° away from the body in order to locate theinvaginated gastroesophageal junction between the body and the anvil.The body contains a staple cartridge holding a plurality of staples, anda staple firing knife. Each of the invagination devices disclosed byBolanos et al. has a jaw member which is rotatable at least 45° and insome cases more than 90° to an open position for grasping thegastroesophageal junction. One of the chief disadvantages of the methodsand apparatus disclosed by Bolanos et al. is that the stapler and theinvagination device must be both be present in the esophagus at the sametime. With some of the embodiments disclosed, the presence of bothinstruments is significantly challenged by the size of the esophagus. Inall of the embodiments, the invagination device is always laterallyspaced apart from the stapler. Thus, the stapler cannot staple theinvaginated tissue, per se, but can only staple tissue which islaterally adjacent to the invaginated tissue. The relatively smallrotational movement of the anvil of the stapler further complicates theaccommodation of tissue adjacent to the invaginated tissue. In addition,surgical staples have some inherent disadvantages as compared to otherfasteners. The relatively small surface area of surgical staples allowsthem to pass through tissue over time, thereby unfastening the tissueand allowing the staples to migrate to other parts of the body. Bolanoset al. appears to recognize this disadvantage and proposes theapplication of a bolster or pledger to the tissues prior to stapling.Bolanos et al. do not explain how this can be accomplished transorallyusing the apparatus disclosed. In addition, while Bolanos et al. make abroad reference to other types of fasteners, the substantial sizeconstraints imposed on the apparatus which are delivered transorallywould seem to prohibit any type of fastener other than the staples shownby Bolanos et al. The actuating mechanism of the device disclosed byBolanos et al. is somewhat awkward. In particular, the stapler anvil isbiased to the open position, and it is not clear whether or not thestapler anvil can be locked in a closed position without continuouslyholding down a lever. In addition, it appears that the staple firingtrigger can be inadvertently operated before the anvil is in the closedposition. This would result in inadvertent ejection of staples into thestomach or the esophagus of the patient.

SUMMARY OF THE INVENTION

Accordingly, the present invention is directed to an effector end to beused with generally known endoscopic surgical instruments. Theendoscopic surgical instrument of the present invention includes atorsionally rigid but flexible tube having a proximal end and a distalend, a grasping and fastening end effector coupled to the distal end ofthe tube, and a manual actuator coupled to the proximal end of the tube.The grasping and fastening end effector preferably includes a separategrasper and a separate fastener. The manual actuator is coupled to thegrasper and fastener of the end effector by a plurality of flexiblecables which extend through the flexible tube. The tube preferablycontains a lumen for receiving a manipulable endoscope and the endeffector preferably includes a passage for the distal end of theendoscope. The end effector has a store for a plurality of male fastenerparts, a store for a plurality of female fastener parts, a rotatablefastener head for aligning a male fastener part and a female fastenerpart with tissues there between, a rotatable firing member for pressinga male fastener part through the tissues and into a female fastenerpart, and a rotatable grasper located between the fastener head and thefiring member.

According to presently preferred embodiments, the overall diameters ofthe flexible tube and the end effector (when the fastener head isrotated to the open position and the grasper is rotated to the closedposition) do not exceed approximately 20 mm (and preferably less than 16mm) so that the instrument may be delivered transorally to the fundus ofthe stomach. The end effector preferably includes a substantiallycylindrical stationary part which houses the store of male fastenerparts and the firing member. Male fastener parts are ejected by thefiring member through a substantially radial port in the substantiallycylindrical stationary part of the end effector. The rotatable fastenerhead is hingedly coupled to a distal portion of the stationary part ofthe end effector and is rotatable from a first (open) position whereinthe fastener head is rotated distally away the female fastener shuttle.The presently preferred female fastener shuttle is a sliding tray whichis located adjacent to the store of female fastener parts. The secondbiasing member pushes female fastener parts into the tray and the traymoves laterally away from the store of female fastener parts when therotatable fastener head is moved from the open position to the closedposition.

The rotatable fastener head, the firing member, and the grasper arepreferably each controlled by an individual cable; and the proximalactuator includes three levers, each coupled to a respective cable, forindividually operating the rotatable fastener head, the firing member,and the grasper. According to a presently preferred embodiment, themanual actuator includes a lock-out feature which prevents theinadvertent firing of male fastener members until the fastener head isrotated into the proper position. The manual actuator also includes areleasable lock for locking the grasper in the closed position.

According to one embodiment, the male fastener member is a circular diskwith a central upstanding barbed projection and the female fastenermember is a circular disk with a central hole engageable by the barbedprojection of a male fastener member. According to another, presentlypreferred embodiment, the female from the stationary part to a second(closed) position wherein the fastener head is rotated proximally towardthe stationary part. The store of female fastener parts is preferablycontained within the fastener head and a female fastener shuttle on thefastener head moves a female fastener from the store into alignment withthe substantially radial port when the fastener head is rotated to theclosed position.

The presently preferred store for male fastener parts includes alongitudinal track arranged proximally of the rotatable firing member inwhich male fastener parts are arranged one behind the other. Malefastener parts are moved distally along the track by a first biasingmember. According to one embodiment, the firing member includes a flangewhich blocks distal movement of male fastener parts while a malefastener part is being ejected. According to a presently preferredembodiment, a spring leaf with a pair of bent teeth engages the distalend of the next male fastener part in the track keeping it from movingoff the track. When the firing member moves down to grab another malefastener part, the leaf is deflected allowing the next male fastenerpart to enter the firing member. The presently preferred store forfemale fastener parts includes an orthogonal chamber in which femalefastener parts are stacked on top of each other and a second biasingmember for moving the female fastener parts into a firing position. Thefemale fastener is rectangular with a central hole engageable by thebarbed projection of a male fastener member. The female member ispreferably provided with a plurality of weak peripheral extensions whichallow the member to be held in the shuttle tray, but forcibly removedtherefrom after it is coupled to a male member.

The apparatus of the invention is advantageously utilized in afundoplication procedure. The instrument is prepared by inserting amanipulable endoscope into the proximal end of the instrument andthreading the endoscope through the lumen of the flexible tube outthrough the end of the end effector. With the grasper closed and therotatable fastener head in the first (open) position, the end effectoris inserted into the mouth of the patient and guided down through theesophagus into the stomach with the aid of the endoscope. When the endeffector is distal of the lower esophageal sphincter, the grasper isopened and the end effector is raised toward the fundus so that thefundus and the lower end of the esophagus are located between thestationary part of the end effector and the grasper. The grasper is thenclosed to clamp together the tissue around the juncture of the esophagusand the fundus. With the grasper closed, the rotatable fastener head isclosed, raising it up toward the fundus and lifting the fundus upagainst the esophagus. With the instrument in this configuration, thefiring member is actuated and a male fastener member is ejected out ofthe radial port, through the esophagus and the fundus, and into a femalefastener member which is held by the tray in the rotatable fastenerhead. The firing member is then returned to its initial position movingthe flange or the leaf away from the male fastener store and allowing asecond male fastener to be pushed onto the second rotatable member. Therotatable fastener head is moved to the open position, releasing thefemale fastener, and returning the tray to the store of female fastenersto receive a second female fastener. The grasper is opened and theinstrument may then be repositioned and the above procedure repeateduntil the desired fundoplication is achieved.

According to another aspect, the invention includes an endoscopicsurgical instrument for deploying a two part fastener having a malefastener part and a female fastener part. The surgical instrumentincludes a tube having a proximal end and a distal end. An end effectoris coupled to the distal end of the tube. The end effector is configuredto hold the male fastener part and the female fastener part in opposedrelation. An actuator is coupled to the proximal end of the tube and theactuator is configured to actuate the end effector. According to oneaspect of the invention, a shearing device may be coupled to the distalend of the tube and is configured to shear off a tip of the malefastener part after the male and female fastener parts are moved intolocking relation. According to another aspect of the invention, thesurgical instrument may include a male fastener part having a shaft witha plurality of detent positions. According to yet another aspect of theinvention, the male fastener part may include a base and a shaftpivotally connected to the base.

Additional objects and advantages of the invention will become apparentto those skilled in the art upon reference to the detailed descriptiontaken in conjunction with the provided figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an enlarged broken perspective view of a first embodiment of aflexible endoscopic surgical instrument according to the invention withthe end effector in a fully open position;

FIG. 2 is an enlarged broken perspective view of the distal end of theinstrument of FIG. 1 with the grasper of the end effector in a closedposition;

FIG. 3 is an enlarged broken perspective view of the distal end of theinstrument of FIG. 1 with the end effector in a fully closed position;

FIG. 4 is an enlarged proximal end view of the end effector removed fromthe instrument of FIG. 1;

FIG. 5 is a broken enlarged transparent side elevation view of the endeffector in the fully closed position;

FIG. 6 is a broken enlarged transparent side elevation view of the endeffector in the fully closed position with a male fastener part ejectedinto a female fastener part;

FIG. 7 is an enlarged side elevation view of a male fastener partaccording to the invention;

FIG. 8 is an enlarged top view of the fastener part of FIG. 7;

FIG. 9 is an enlarged side elevation view of a first embodiment of afemale fastener part according to the invention;

FIG. 10 is an enlarged top view of the fastener part of FIG. 9;

FIG. 11 is an enlarged schematic view of the distal end of theinstrument of FIG. 1 adjacent the gastroesophageal junction in a firstoperative position;

FIG. 12 is a view similar to FIG. 11 of the instrument in a secondoperative position;

FIG. 13 is a view similar to FIG. 11 of the instrument in a thirdoperative position;

FIG. 14 is a view similar to FIG. 11 of the instrument in a fourthoperative position;

FIG. 15 is a view similar to FIG. 11 of the instrument in a fifthoperative position;

FIG. 16 is a side elevation view of one side of a presently preferredmanual actuator in a first operative position (grasper closed andfastener head open) with the near side of the casing removed;

FIG. 17 is an isometric view of one side of the actuator of FIG. 16 withthe near side of the casing removed;

FIG. 18 is a side elevational view of the other side of the actuator ofFIG. 16 with the near side of the casing removed;

FIG. 19 is an isometric view of the other side of the actuator of FIG.16 with the near side of the casing removed;

FIG. 20 is a view similar to FIG. 16 with the actuator in a secondoperative position (grasper open and fastener head open);

FIG. 21 is a view similar to FIG. 16 with the actuator in the midpoint athird operative position (grasper closed and fastener head partiallyclosed);

FIG. 22 is a view similar to FIG. 16 with the actuator in a fourthoperative position (grasper closed and fastener head closed);

FIG. 23 is a view similar to FIG. 16 with the actuator in a fifthoperative position (grasper closed, fastener head closed, and malefastener part fired);

FIG. 24 is a view similar to FIG. 21 of the other side of the manualactuator;

FIG. 25 is a perspective view of a presently preferred embodiment of theend effector in a first operative position;

FIG. 26 is a perspective view of the presently preferred embodiment ofthe end effector in a second operative position;

FIG. 27 is a perspective view of the presently preferred embodiment ofthe end effector in a third operative position;

FIG. 28 is a perspective view of the distal end of the presentlypreferred embodiment of the end effector in the third operativeposition;

FIG. 29 is a perspective view of the proximal end of the presentlypreferred embodiment of the end effector in the third operativeposition;

FIG. 30 is a perspective view of the major components of the presentlypreferred embodiment of the end effector in the third operativeposition;

FIG. 31 is a perspective view of the major components of the presentlypreferred embodiment of the end effector in a fourth operative position;

FIG. 32 is a perspective view of the stationary component and thegrasper of the presently preferred embodiment of the end effector;

FIG. 33 is a perspective view of the grasper component and the fastenerfiring component of the presently preferred embodiment of the endeffector;

FIG. 34 is a view similar to FIG. 33 of the other side of the graspercomponent and the fastener firing component;

FIG. 35 is a perspective view of the top side of a presently preferredembodiment of a female fastener part in the female fastener carrier;

FIG. 36 is a perspective view of the bottom of the presently preferredfemale fastener part;

FIG. 37 is a perspective view of the presently preferred female fastenerpart coupled to the male fastener part;

FIG. 38 is a broken, partially cut away perspective view of an alternatepreferred embodiment showing the firing member receiving a male fastenerpart;

FIG. 39 is a view similar to FIG. 38 from a different perspective;

FIG. 40 is a view similar FIG. 39 showing the firing member raised andthe leaf preventing a male fastener part from moving off the track;

FIG. 41 is a broken perspective view of the embodiment of FIGS. 38-40showing the end effector with the firing member with a male fastenerpart engaged therein;

FIG. 42 is a perspective view of the firing member and male fastenerpart engaged therein by a leaf spring;

FIG. 43 is a perspective view of the firing member with the leaf springdisengaged from the male fastener part to release the male fastenerpart;

FIG. 44 is a perspective view showing the end effector with the firingmember with a male fastener part with the leaf spring disengaged fromthe male fastener part to release the male fastener part;

FIG. 45 is a broken, partially cut away perspective view of theembodiment of FIGS. 38-44 showing the store of female fastener partswith a female fastener part in position to receive a male fastener part;

FIG. 46 is a broken perspective view of the embodiment of FIGS. 38-45showing the female fastener part shuttle in position to retrieve afemale fastener part from the store of female fastener parts;

FIG. 47 is a broken, partially cut away perspective view of theembodiment of FIGS. 38-46 showing the female fastener part shuttle in anintermediate position;

FIG. 48 is a broken, partially cut away perspective view of theembodiment of FIGS. 38-47 showing the female fastener part and malefastener parts coupled with the ejector spring engaging the barb of themale fastener part;

FIG. 49 is a perspective view of an end effector according to anembodiment of the present invention showing male and female fastenerparts in position on the end effector;

FIG. 50 is a perspective view of portions of the internal frame of theend effector of FIG. 49, showing a shearing mechanism in relation to thefemale fastener part;

FIG. 51 is a perspective view of portions of the internal frame of theend effector of FIG. 49, showing the shearing mechanism severing the tipof the male fastener part as the fastened connector is ejected from theend effector;

FIGS. 52 and 53 are perspective views of a hinged male fastener partaccording to an embodiment of the present invention;

FIGS. 54 and 55 are perspective views of the hinged male fastener partof FIGS. 52 and 53 mated with a female fastener part;

FIGS. 56 and 57 are perspective views of an alternative embodiment of ahinged male fastener; and

FIGS. 58 and 59 are side elevations of the male fastener part showinghow the end effector arm causes the shaft to rotate into position.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to FIGS. 1 through 4, a first embodiment of an endoscopicsurgical instrument 10 includes a torsionally rigid but flexible tube12, preferably made from polyethylene, and having a proximal end 14 anda distal end 16, a grasping and fastening end effector 18 coupled to thedistal end 16 of the tube 12, and a manual actuator 20 coupled to theproximal end 14 of the tube 12. The manual actuator 20 is coupled to theend effector 18 by three flexible cables 22, 24, 26 which extend throughthe flexible tube 12. Each of the cables is preferably formed from anouter coil sheath 22 a, 24 a, 26 a, and an inner pull wire 22 b, 24 b,26 b. The actuator 20 includes three levers 22 c, 24 c, 26 c which arecoupled to respective pull wires 22 b, 24 b, 26 b. The tube 12 alsocontains a lumen 28 for receiving a manipulable endoscope 2 and the endeffector 18 includes a passage 30 for the distal end 4 of the endoscope2. Preferably, the overall diameters of the flexible tube 12 and the endeffector 18 (when in the position shown in FIG. 2) do not exceedapproximately 20 mm (and are preferably no more than 16 mm) so that theinstrument may be delivered transorally through the esophagus to thefundus of the stomach.

The end effector 18 has a substantially cylindrical stationary member31, a rotatable fastener head 40, and a grasper 42. The stationarymember 31 has a relatively flexible proximal portion 32 and a relativelyrigid distal, portion 34. The distal portion is rigid so that a store ofmale fastener parts and firing member can be located therein. The lengthof the rigid portion depends on the number of male fastener partsdesired to be stored. The distal portion 34 has a flattened part 36which angles down toward the distal end 38 of the stationary member 31.As will be described in more detail below with reference to FIGS. 5 and6, the rotatable fastener head 40 is coupled to the distal end of theflattened portion 36 and is rotatable toward and away from the flattenedportion 36 as seen best in FIGS. 2 and 3. The rotatable grasper 42 iscoupled to the distal end of the flattened portion 36 proximal of therotatable fastener head 40 and is rotatable toward and away from theflattened portion 36 as seen best in FIGS. 1 and 2. The rotatablefastener head 40 is coupled to the cable 24 so that its movement iscontrolled by the lever 24 c and the grasper 42 is coupled to the cable26 so that its movement is controlled by the lever 26 c.

Referring now to FIGS. 4-6, the stationary member 31 of the end effector18 includes a store 44 for male fastener parts, e.g. 46, and asubstantially radial port 48 through which male fastener parts areejected. As will be described in more detail below with reference toFIGS. 7 and 8, the male fasteners have a substantially T-shaped profileand the store 44 is a substantially T-shaped track which is dimensionedto hold approximately six male fastener parts. A biasing spring 50 urgesthe male fasteners distally along the track into position adjacent theport 48. A rotatable firing member 52 is located adjacent to the distalend of the track 44 and is coupled to the cable 22. Thus, operation ofthe lever 22 c (FIG. 1) rotates the rotatable firing member 52 therebyejecting a male fastener part through the port 48. A lower flange 54 onthe member 52 prevents distal movement of the fastener parts in thetrack 44 until the member 52 is rotated back to its original position.

Referring generally to FIGS. 1-6, the rotatable fastener head 40includes a store 56 for female fastener parts, e.g. 57, and a slidingtray 58 for moving female fastener parts out of the store 56. Thesliding tray 58 is moved automatically by a wire link 60 which causesthe tray to move away from the store 56 when the rotatable fastener head40 is rotated from the open position (FIGS. 1 and 2) to the closedposition (FIGS. 3-6). As will be described in more detail below withreference to FIGS. 9 and 10, according to one embodiment, the femalefastener parts are generally disk shaped and are held in a stack in thestore 56. A spring 62 biases the fastener parts into the tray 58 whenthe rotatable fastener head 40 is in the open position. The tray 58 isdimensioned such that a single fastener part is retrieved from the stackand moved in the tray to a position opposite to the port 48 when therotatable fastener head 40 is rotated from the open position to theclosed position.

Turning now to FIGS. 7-10, a presently preferred male fastener part 46has a disk shaped base 46 a, a central upstanding shaft 46 b, andtapered barb 46 c at the end of the shaft. According to a preferredembodiment, the base is approximately 0.3 inches in diameter andapproximately 0.040 inches thick, the upstanding member is approximately0.140 inches tall, and the barb is approximately 0.10 inches long. Afirst embodiment of a female fastening member 57 is a substantially flatdisk 57 a, having a central hole 57 b, and four radially outwardextending peripheral tabs 57 c-57 f. Four radial strain relief slits 57g-57 j are preferably provided adjacent to the hole 57 b. The femalefastener is approximately 0.3 inches in diameter and approximately 0.040inches thick. Both the male fastener and the female fastener parts aremade from biocompatible polymers. The barb 46 c, the shaft 46 b, and thehole 57 b are dimensioned such that the barb may be forced through thehole to lock the fastener parts together, but that once locked together,the parts will not easily separate. The peripheral tabs 57 c-57 f aredimensioned such that they hold the female fastener part in the slidingtray prior to being locked together with the male fastener part, butthat they allow the female fastener part to be pulled out of the trayafter it is locked together with the male fastener part. For example,the tabs are thin enough to bend, flex, or shear off when the femalefastener part is pulled out of the tray.

As mentioned above, the instrument of the invention is advantageouslyutilized in a fundoplication procedure. With reference now to FIGS. 1, 2and 11-15, the instrument 10 is prepared by inserting a manipulableendoscope 2 into the proximal end of the instrument and threading theendoscope through the lumen of the flexible tube 12 out through the endof the end effector 18. With the grasper 42 closed and the rotatablefastener head 40 in the first (open) position (as shown in FIGS. 2 and11, the end effector 18 is inserted into the mouth of the patient andguided down through the esophagus 3 into the stomach 5 with the aid ofthe endoscope 2. When the grasper 42 and the rotatable fastener head 40are distal of the fundus 7, the grasper 42 is opened as shown in FIG. 12and the end effector is raised toward the fundus 7 so that the fundusand the lower end of the esophagus 3 are located between the stationarypart 31 of the end effector and the grasper 42. The grasper 42 is closedto hold the gastroesophageal junction as shown in FIG. 13. The rotatablefastener head 40 is then rotated to the closed position, raising it uptoward the fundus 7 and lifting the fundus 7 up against the esophagus 3as shown in FIG. 14. With the instrument in this configuration, therotatable firing member (52 in FIGS. 5 and 6) is actuated and a malefastener member 46 is ejected out of the radial port 48, through theesophagus 3 and the fundus 7, and into a female fastener member 57 asshown in FIG. 15. The rotatable firing member is then returned to itsoriginal position, moving the flange 54 away from the male fastenerstore 44 and allowing a second male fastener to be pushed onto thesecond rotatable member 52. The rotatable fastener head 40 is moved tothe open position, releasing the female fastener, and returning the trayto the store of female fasteners to receive a second female fastener.The grasper 42 is opened and the instrument may then be repositioned andthe above procedure repeated until the desired fundoplication isachieved.

FIGS. 16 through 24 show a presently preferred manual actuator 100,according to the invention, which is provided with a lock-out feature toprevent the inadvertent firing of a male fastener member before therotatable fastener head is in the proper position and with a lockablelever for holding the grasper in the closed position. Referring now toFIGS. 16-20, and as seen best in FIGS. 17 and 19, the actuator 100 has agenerally pistol-shaped housing 101 which is formed from two matinghalves 102, 104. By generally pistol-shaped, it is meant that thehousing has a grip portion 108 and a barrel portion 109. Three levers(106, 118, 136) and a toothed cam (122) are rotatably mounted within thehousing.

The first lever 106 is mounted adjacent to the gripping portion 108 ofthe housing and is pivotally coupled at its upper end to the housing bya pin 110. A slotted throughbore 112 in the lever 106 is located belowthe pin 110. The slotted throughbore 112 receives the proximal end ofcable 26 (which controls the grasper) and the cable is attached to thelever 106 by a crosspin 114. The lower end of the lever 106 is providedwith a spring biased latch 116 which is operatively engageable with anotch (not shown) in the housing.

The second lever 118 is pivotally coupled at one end 120 to the proximalend of the toothed cam 122. The second lever 118 is also provided with aslotted throughbore 124 which receives the proximal end of cable 22(which controls the fastener firing member). The proximal end of thecable 22 is coupled to the lever 118 by a crosspin 126 in the slottedthroughbore 124. The slotted throughbore 124 is located in a portion 118a of the lever 118 which is broader than an immediately adjacent portion118 b. A locking stop 113 is provided in housing half 104 (FIG. 18)which blocks movement of the broad portion 118 a of the lever asdescribed in more detail below.

The toothed cam 122 is rotatably coupled to one portion 102 of thehousing by a pin 128 which is located between the grip portion 108 andthe barrel portion 109 of the housing. This portion of the housing isprovided with a slotted wall 111 (FIG. 16) through which the first andsecond levers 106, 118 exit the housing. The slot in the wall 111 isdimensioned to allow passage of the portion 118 b of the lever 118 andmay be dimensioned to prevent the passage of the broader portion 118 a.The cam 122 has a distal curved slotted throughbore 130 which receivesthe proximal end of cable 24 (which controls the rotatable fastenerhead). The proximal end of cable 24 is coupled to the cam 122 by acrosspin 132 which rides in the curved throughbore 130. The cam 122 isprovided with a plurality of peripheral teeth 134 which extend along acurved path from the proximal end of the cam where the lever 118 iscoupled to it, to a point adjacent to the curved throughbore.

The third lever 136 is rotatably mounted above the cam 122 by a pin 138and is provided with a plurality of radial teeth 140 which engage theteeth 134 of the cam 122.

The housing 101 is also provided with a plurality of cable guides 142(FIG. 17) in the barrel portion 109 of the housing half 102 and anendoscope receiving tube 144 (FIG. 18) in the barrel portion 109 of thehousing half 104. In addition, the housing halves 102, 104 are providedwith longitudinal guide slots 146, 148 which engage the crosspin 132 andguide its motion in a longitudinal direction.

The operation of the actuator 100 is described in sequence withreference to FIGS. 16-24 and with reference to the presently preferredend effector configuration of FIGS. 25-31 which are discussed in moredetail below. FIGS. 16-19 show the positions of the levers 106 and 136when the grasper is closed and the fastener head is opened (see alsoFIG. 25). In this position of lever 136, the lever 118 is positioned sothat it is impossible to move the lever 118 to fire a male fastener. Inparticular, the distal location of lever 136 has caused the radial teeth140 to rotate the cam 122 proximally which has moved the pivot point 120of the lever 118 to a position proximal of its broad portion 118 a. Inorder to move the lever 118, the broad portion 118 a needs to pass thestop 113 (FIG. 18) which prevents its movement. In addition, since thelever 118 must rotate about the pivot point 120, the portion 118 a needsto exit the slot 111 in the housing. However, as described above, theslot may be dimensioned to prevent this movement. With the levers in thepositions shown in FIGS. 16-19, the instrument is in the properorientation for delivery through the esophagus. It will also beappreciated that the positions and locations of the levers are easy tounderstand and provide intuitive indication of the positions of theparts of the end effector. For example, the lever 106 is “closed”relative to the grip 108 indicating that the grasper is closed. Thelever 136 is approximately 180° forward indicating that the fastenerhead is rotated forward (distally) approximately 180°. The lever 118,which is most like the trigger portion of the pistol shaped actuator israised up and out of the way where it cannot be pulled.

After the end effector is in place at the surgical site, the grasper isopened (to the position shown in FIG. 26) by releasing the latch 116 andmoving the lever 106 distally as shown in FIG. 20; thereby moving cable26 which is attached to the grasper 206. After the grasper has beenproperly positioned, the lever 106 is moved back and the latch 116 holdsthe grasper locked closed (in the position shown in FIG. 25).

The rotatable fastener head is now closed (to the position shown inFIGS. 27-30) by rotating the lever 136 proximally which is shown in twostages in FIGS. 21 and 22. As seen in comparing FIGS. 20, 21, and 22, asthe lever 136 is rotated proximally, the teeth 140 on the lever 136engage the teeth 134 on the cam 122 causing the cam 122 to rotatedistally. This action causes the curved slot 130 to rotate in a mannerwhich forces the cross pin 132 to move distally in the slots 146, 148.Movement of the crosspin 132 moves the cable 24 distally causing thefastener head to close. At the same time, the pivot point 120 of thelever 118 is rotated above the broad portion 118 a of the lever 118.This moves the broad portion 118 a above the stop 113 and places thelever 118 in a position where the broad portion 118 a does not need toexit the slot 111 and can freely pass alongside the stop 113. As shownin FIG. 22, the lever 118 is now operable to fire a male fastener. Itwill be appreciated that, until the fastening head is completely closed,movement of the firing lever 118 to pull the cable 22 is prevented bythe stop 113. In addition, it will be appreciated that the crosspincoupling 126 remains stationary as the cam 122 causes the lever 118 tobe rotated about this pin.

FIG. 23 shows the lever 118 moved to the proximal position which pullsthe cable 22 proximally and fires the male fastener part (as shown inFIG. 31). As seen best in FIG. 24, when the firing lever is in theproximal position, the stop 113 is located below the broad portion 118a. It will be appreciated that this position of the lever 118 willprevent the lever 136 from being moved distally. Distal movement of thelever 136 will attempt to rotate the cam 122 in a manner which will movethe lever 118 in a direction where its broad portion 118 a must pass thestop 113. Therefore, before the lever 136 can be moved to open thefastener head, the firing lever 118 must be moved back to the positionshown in FIG. 22. As show in FIGS. 23 and 24, the lever 118 ispreferably concave along its proximal side so that it can be moved overthe lever 106.

Turning now to FIGS. 25-37, the presently preferred end effector andfasteners are similar to those described above with reference to FIGS.1-10 with some differences which will become apparent from the followingdescription.

The end effector 200 has a substantially cylindrical stationary member202, a rotatable fastener head 204, and a grasper 206. The stationarymember 202 has a relatively flexible proximal portion 208 and arelatively rigid distal portion 210. The distal portion 210 has aflattened part 212 which angles down toward the distal end 214 of thestationary member 202. The flattened part 212 is provided with a firstgrasping surface 216 and the grasper 206 is provided with a secondgrasping surface 218. A male fastener exit port 220 is locatedintermediate of the flattened part 212 and the proximal portion 208. Asseen best in FIGS. 30 and 31, a firing member 222 with a movable malefastener part holder 224 is located inside the stationary member 202. Asseen best in FIG. 29, a store 226 of male fastener parts 227 is locatedinside the stationary member 202, proximal of the firing member 222.Individual male fastener parts 227 a are biased from the store into themale fastener part holder 224 by a spring 229 as shown in FIG. 30.According to this embodiment, up to six male fastener parts are held inthe store. As seen best in FIGS. 28 and 29, an endoscope port 228 isprovided in the stationary member 222 below the male fastener part store226. Three cable ports 230, 232, 234 are provided in the stationarymember 202 as shown in FIG. 29 for attaching control cables to thegrasper 206, the fastener head 204, and the firing member 222,respectively.

The rotatable fastener head 204 includes a store 236 of female fastenerparts 237 and a movable tray 238 for moving female fastener parts out ofthe store and into position to receive a male fastener part as describedbelow. According to this embodiment, up to six female fastener parts areheld in the store. The movable tray 238 is coupled to the fastener head204 by flanges 238 a, 238 b which slideably engage grooves 204 a, 204 bin the fastener head as seen best in FIGS. 27-30. The movable fastenerhead 204 is coupled to the distal end 214 of the stationary member 202by a pivot axle 240, and a hinged link 242 (FIG. 28) couples thefastener head 204 to a control cable (not shown). When the link 242 ismoved distally, the fastener head 204 is moved to the closed position asshown in FIG. 28. When in this position, the hinge 242 a in the link 242is moved past the center of the pivot axle 240 which locks the fastenerhead in the closed position. The sliding tray 238 is coupled via aflange 238 c and a pivoting link 244 to the pivot axle 240 as seen bestin FIGS. 25 and 26. This link 244 causes the tray 238 to slide from theposition shown in FIGS. 25 and 26 to the position shown in FIGS. 27 and28 when the fastener head 204 is closed.

The firing member 222 is coupled to the stationary member 202 by thesame pivot axle 240 as the fastener head as shown in FIGS. 25, 26, 30,33, and 34. The firing member 222 is coupled to a control cable (notshown) by a lower flange 222 a as shown in FIGS. 30, 33, and 34. Asshown in FIG. 32, the distal portion 210 of the stationary member 202 isprovided with a stepped port 234 through which the control cable for thefiring member passes and which holds the cable sheath. When the controlcable pulls the flange 222 a proximally, the firing member 222 is movedtowards the exit port 220. The movable male fastener part holder 224 isprovided with a proximal flange 224 a which is coupled to a lateralportion 210 a of the stationary member 202 by a pivoting link 246 asseen best in FIG. 30. This link 246 causes the holder 224 to slidedistally as shown in FIG. 31 when a male fastener part is fired. Thepurpose of the holder 224 is to prevent the male fastener part fromfalling out through the port 220 when the fastener head is open and toallow the firing operation to be aborted while retaining the malefastener part.

As seen best in FIGS. 33 and 34, the grasper 206 is pivotally coupled tothe distal end of the firing member 222 on a pivot axle 250. The grasper206 is also coupled to a control cable (not shown) via a hole 252located above its pivot connection. As shown in FIGS. 31 and 32, thedistal portion 210 of the stationary member 202 is provided with astepped port 230 through which the control cable for the grasper passesand which holds the cable sheath. When the control cable is pulledproximally, the grasper is moved to the closed position shown in FIG.25.

Turning now to FIGS. 35-37, the presently preferred male fastener part227 (substantially the same as the fastener part 46 described above) hasa disk shaped base 227 a, a central upstanding shaft 227 b, and taperedbarb 227 c at the end of the shaft. The presently preferred femalefastening member 237 is a substantially flat rectangular member 237 adefining a central hole 237 b. The hole 237 b has a tapered entry 237 cand four radial strain relief slots 237 d. Four flexible or frangibleperipheral tabs 237 e are provided on the periphery of the rectangularmember. These tabs hold the fastener part in the tray 238 as shown inFIG. 35, but allow it to be pulled out of the tray after it is coupledto a male fastener part as shown in FIG. 37.

Turning now to FIGS. 38-48, an alternate preferred end effector 300 issimilar to the end effector 200 described above, with similar referencenumerals referring to similar parts.

The end effector 300 has a substantially cylindrical stationary member302, a rotatable fastener head 304, and a grasper 306. The stationarymember 302 has a flattened part 312 which angles down toward the distalend 314 of the stationary member 302. The flattened part 312 is providedwith a first grasping surface 316 and the grasper 306 is provided with asecond grasping surface 318. A male fastener exit port 320 is located atthe proximal end of the flattened part 312. As seen best in FIGS. 38-44,a firing member 322 with a male fastener part holder 324 is locatedinside the stationary member 302.

As seen best in FIGS. 41-44, the holder 324 has a pair of flangedspringy arms 324 a, 324 b which hold the base of a male fastener part,e.g. 327 a. The arms 324 a, 324 b are biased outward to the positionshown in FIG. 43. As seen best in FIGS. 41 and 44, the interior of thestationary member 302 has contoured walls 303 a, 303 b which hold thearms 324 a, 324 b close together, securing the male fastener part. Whenthe firing member 322 is raised into the firing position, as shown inFIGS. 40 and 44, the springy arms 324 a, 324 b move outward as shown inFIG. 43, thereby releasing the male fastener part.

As seen best in FIGS. 38-40, a store 326 of male fastener parts 327 a,327 b, etc. is located inside the stationary member 302, proximal of thefiring member 322. Individual male fastener parts 327 a, 327 b, etc. arebiased from the store into the male fastener part holder 324 by a spring(not shown). According to this embodiment, a leaf spring 325 having anupstanding flange 325 a and a distal tongue 325 b (FIG. 40) is arrangedbeneath the row of male fastener parts in the store 326. As shown inFIG. 40, the distal most fastener part is prevented from exiting thestore 326 by the flange 325 a when the firing member 322 is in thefiring position. When the firing member 322 returns from the firingposition as seen in FIGS. 38 and 39, the tongue 325 b of the leaf springis depressed by the firing member 322 and the flange 325 a is therebymoved away from the next fastener part allowing it to enter the holder324 of the firing member 322.

As seen best in FIGS. 41, 44, and 48, an endoscope port 328 is providedin the stationary member 322 below the male fastener part store 326.Three cable ports 330, 332, 334 are provided in the stationary member302 as shown in FIGS. 41 and 44 for attaching control cables to thegrasper 306, the fastener head 304, and the firing member 322,respectively.

As shown in FIGS. 41-48, the rotatable fastener head 304 includes astore 236 of female fastener parts 337 and a movable tray 338 for movingfemale fastener parts out of the store and into position to receive amale fastener part as described below. According to this embodiment, upto six female fastener parts are held in the store. As seen best in FIG.44, the movable tray 338 is coupled to the fastener head 304 by flanges338 a, 338 b which slideably engage flanges 304 a, 304 b in the fastenerhead. The sliding tray 338 is coupled via a flange 338 c and a pivotinglink 344 to the pivot axle 340 as seen best in FIGS. 44, 45, and 48.This link 344 causes the tray 338 to slide from the position shown inFIG. 44 to the position shown in FIGS. 45 and 48 when the fastener head304 is closed.

As seen best in FIGS. 45-48, the female fastener parts 337 a-337 e arebiased out of the store 336 by a bifurcated leaf spring 305 and are heldlaterally in line by a support post 307 which is seen best in FIG. 46where the movable tray has been removed to better expose the spring 305and the post 307. A fastener discharge spring 309 is located adjacent tothe female fastener store 336 and is provided with a male fastenerengaging surface 311. As the fastener head 304 is moved from the openposition shown in FIG. 46 to the closed position shown in FIG. 45, themovable tray 338 moves the top most female fastener part 337 a out ofthe store and over the discharge spring 309. FIG. 47 shows the tray 338in a midway position as the fastener 337 a is being moved into positionto receive a male fastener part. When a male fastener is fired into thefemale fastener as shown in FIG. 48, The end of the male fastener willengage the surface 311 on the spring 309 and compress the spring. Itwill be appreciated that as the firing member 322 is returned from thefiring position, the spring 309 will push against the end of the malefastener thereby pushing the female fastener out of the tray, bending orbreaking the tabs of the female fastener.

The firing member 322 is coupled to the stationary member 302 by thesame pivot axle 340 as the fastener head as shown in FIGS. 39, 40, 42,43 and 48. The firing member 322 is coupled to a control cable (notshown) by a lower flange 322 a as shown in FIG. 48. When the controlcable pulls the flange 322 a proximally, the firing member 322 is movedtowards the exit port 320.

FIGS. 49-51 show an end effector 400 of a surgical instrument accordingto another embodiment of the present invention. End effector 400includes a first actuator arm 401 pivotally connected to a secondactuator arm 402 by a suitable pivoting mechanism 403. Pivotingmechanism 403 can include a pivot pin (not shown) that extends throughan aperture 404 extending through proximal ends 401 a, 402 a of actuatorarms 401, 402, respectively. End effector 400 also may be used incombination with aspects of the various embodiments of surgicalinstruments described above. For example, end effector 400 may include agrasping mechanism, such as those described in connection with endeffectors described above or may be used in an endoscopic procedure incombination with a separate grasping instrument. End effector 400 alsomay connect to a distal end of an elongate tube, such as a distal end ofthe elongate, flexible tubes described above, in any suitable mannerknown in the art. End effector 400 also may be operated by a proximalactuator that is coupled to end effector 400 by a suitable controlmechanism such as those described above.

End effector 400 is configured to hold a male fastener 406, as shownpositioned on actuator arm 401. Male fastener 406 has a base 406 a, ashaft 406 b, and a tip 406 c. The tip 406 c is provided with multipledetent positions 406 c-1, 406 c-2, and 406 c-3 defined by barbs 406 d-1,406 d-2, and 406 d-3. The male fastener depicted herein has three suchbarbs, but any number of barbs and corresponding detent positions couldbe provided as required by, for example, the thickness of tissue to befastened together and the procedure to be performed.

FIGS. 52 and 53 show an alternative configuration of a male fastener 506to be used with end effector 400. Here, male fastener 506 is providedwith a base 506 a and a shaft 506 b that has a tip 506 c, similar tothat depicted in FIGS. 49-51. At the base of shaft 506 b are providedrounded tabs 506 d that fit into slots 506 e formed into base 506 a.Tabs 506 d resting in slots 506 e permit shaft 506 b to rotate in ahinge-like fashion from a retracted position (FIG. 52) to a deployedposition (FIG. 53). The ability of shaft 506 b to attain a retractedposition lying in substantially the same plane as that of base 506 aallows the male fastener assembly to be more easily stored in a smallerspace within the surgical instrument. This flat storage configurationcan allow for storage of a larger number of male fasteners and/or use ofa smaller size end effector, reducing trauma to the patient. Thisconfiguration also allows for a longer shaft than could be used with anon-retractable fastener. In addition, a deployment tab 506 f may beprovided at the base of shaft 506 b. In operation, as male fastener 506is moved into position at the distal end of effector arm 401, tab 506 fwould come into contact with a surface on arm 401 that would then applyforce to tab 506 f, causing shaft 506 b to rotate into a deployedposition. Once deployed, male fastener 506 would then operate in asimilar same fashion as a non-retractable male fastener, such as thosedescribed above.

FIGS. 58 and 59 show fastener 506 in relation to ejector arm 401 b.Ejector arm 401 b is provided with an opening 401 d that interacts withtab 506 f. End effector 401 is provided with a push wire (not shown)that provides a pushing force onto ejector arm 401 b. As arm 401 b ismoved distally, the trailing edge of window 401 d contacts tab 506 fcausing shaft 506 b to rotate into position to mate with female fastenerpart 508.

FIGS. 54 and 55 show male fastener 506 of FIGS. 52 and 53 mated with afemale fastener 408. Female fastener 408 includes a central hole 408 ainto which tip 506 c of male fastener 506 is capable of entering. Fourradial strain relief slots 408 b are provided to allow for barbed tip406 c to more easily slide into and mate with female connector 408. Tworibs 408 c are provided on a side of female fastener 408 opposite theside through which shaft 506 b enters to provide for further structuralsupport within the fastener. Female fastener 408 also has threeindentations 408 d around the periphery on the side opposite the sidecontaining ribs 408 c to allow for fastener 408 to be held in place atthe distal end of actuator arm 402 of end effector 400, as best shown inFIG. 49. As shown in FIG. 49, actuator arm includes fingers 450corresponding to indentations 408 d to hold fastener 408 in place. Thesefingers 450 will release from fastener 408 once fastener 408 mates witha male fastener part.

FIGS. 56 and 57 show a further embodiment of a male fastener 606 to beused in connection with end effector 400. In this embodiment, malefastener 606 includes a base 606 a and a shaft 606 b having a tip 606 cthat are similar in most respects to those already described. Malefastener 606, however, includes an alternative mechanism 606 g forproviding pivotal movement of shaft 606 b relative to base 606 a.Mechanism 606 g is in the form of a living hinge. In other words, shaft606 b is formed to connects with base 606 a through a thinned outportion of biocompatible material that has sufficientflexibility/bending to permit shaft 606 b to pivot relative to base 606a, yet not disconnect from base 606 a. Like the prior describedembodiment, male fastener 606 includes a deployment tab 606 f at thebase of shaft 606 b. In operation, as male fastener 606 is moved intoposition at the distal end of effector arm 401, tab 606 d would comeinto contact with a surface on arm 401 that would then apply force totab 606 f, causing shaft 606 b to rotate into a deployed position. Malefastener 606 also includes a plurality of indentations or slots 606 hthat allow fastener 606 to be held in place at the distal end ofeffector arm 401, similar to slots 408 d of female fastener 408 andcorresponding fingers 450 of arm 402.

FIGS. 50 and 51 show certain internal portions of actuator arms 401,402. For example, each arm 401, 402 of end effector 400 includes anejector arm 401 b, 402 b and a frame member 401 c, 402 c, respectively.Frame members 401 c, 402 serve to hold the male and female fastenersrespectively in place prior to locking, as shown in FIG. 50. In thatposition, arms 401 b, 402 b are in a proximal position relative tocorresponding members 401 c, 402 c. FIG. 51 shows the male and femalefasteners in lacking relation and being ejected from the end effector.To eject the locked fastener, arms 401 b, 402 b move distally relativeto corresponding members 401 c, 402 c in a sliding motion.

As arms 410 b, 402 b force the locked fastener off of end effector 400,a shearing mechanism 410 positioned at the distal end of actuator arm402 and beneath female connector 408 will sever tip 406 c of the malefastener. That tip first passes through an opening 412 when the male andfemale fasteners mate. As the coupled fastener is released from endeffector 400 by ejector arms 401 b, 402 b, the tip is severed by thedistal end of member 402 c by the tip, at a detent position, beingforced against an edge of opening 412 and pulled away from the fastener.This can be made possible by manufacturing the male fastener part withthinned shaft regions at the detent positions between the barbs so thatthe portion of the tip protruding through the female fastener is moreeasily pulled away from the shaft. Positioned inside the opening 412 canbe a sharp surface, for example a blade, to shear the tip of the malefastener shaft. Other suitable shearing mechanisms that could fit intothe effector arm may be used.

With a multiple barbed fastener, the shearing device shears off only theportion of the shaft that protrudes through the opening in the femalefastener. For example, if the female fastener were positioned above barb406 d-2 at detent position 406 c-1, then only barb 406 d-1 would besevered from the shaft. The shearing mechanism is positioned proximatethe female fastener so that the sharing mechanism removes as much of theshaft tip as possible but still leaves enough of the tip that isnecessary to keep the fastener together. The removal of the shaft tip bythe shearing mechanism reduces trauma to the patient that otherwise maybe caused by a sharp tip.

In operation, actuator arms 401, 402 pivoted together so that the shaftof a male fastener insert into the opening in a female fastener. Unlikeprior fasteners having a single barb, there was no possibility to adjustthe fastener either to alter the pressure applied by the fastener to thetissue or to vary with the thickness of tissue to be fastened. By addingmultiple barbs and corresponding detent positions, the fastener can beused to fasten various thicknesses of tissue and can allow a physicianto adjust the amount of pressure applied to the tissue by the fastener.

There have been described and illustrated herein several embodiments ofa flexible endoscopic surgical instrument for invagination andfundoplication. While particular embodiments of the invention have beendescribed, it is not intended that the invention be limited thereto, asit is intended that the invention be as broad in scope as the art willallow and that the specification be read likewise. It will therefore beappreciated by those skilled in the art that yet other modificationscould be made to the provided invention without deviating from itsspirit and scope as so claimed.

What is claimed is:
 1. An endoscopic surgical instrument for deploying atwo part fastener having a male fastener part and a female fastenerpart, comprising: a tube having a proximal end and a distal end; an endeffector coupled to said distal end of said tube, said end effectorconfigured to hold the male fastener part and the female fastener partin opposed relation; an actuator coupled to said proximal end of saidtube and configured to actuate the end effector; and a shearing deviceproximate said end effector and configured to shear off a tip of saidmale fastener part after the male and female fastener parts are movedinto a locking relation and during ejection of the male and femalefastener parts from the end effector.
 2. The endoscopic surgicalinstrument of claim 1, wherein said end effector comprises first andsecond effector arms connected in pivotal relation, wherein the firsteffector arm is configured to hold the male fastener and the secondeffector arm is configured to hold the female fastener.
 3. Theendoscopic surgical instrument of claim 2, wherein said effector armseach include a frame member and an ejector arm, wherein said framemember and said ejector arm are configured to move in a sliding relationso as to eject the respective male and female fastener parts in saidlocking relation from the end effector.
 4. The endoscopic surgicalinstrument of claim 2, wherein said shearing device is positioned at adistal end of said second effector arm.
 5. The endoscopic surgicalinstrument of claim 4, wherein said shearing device includes a holedefined by said second effector arm, the hole having an edge that iscapable of shearing the tip.
 6. The endoscopic surgical instrument ofclaim 3, wherein the shearing device is fixed relative to a distal endof one of the frame members.
 7. The endoscopic surgical instrument ofclaim 1, wherein the shearing device is fixed relative to a portion ofthe end effector configured to hold one of the male fastener part andthe female fastener part.
 8. The endoscopic surgical instrument of claim2, wherein the shearing device is fixed relative to a distal portion ofone of the first and second end effector arms.
 9. The endoscopicsurgical instrument of claim 1, wherein said male fastener part includesa base and a shaft connected to the base, wherein the shaft includes aplurality of detent positions.
 10. The endoscopic surgical instrument ofclaim 9, wherein the female fastener part is capable of resting in saidlocking relation at each of said detent positions.
 11. The endoscopicsurgical instrument of claim 1, wherein said tube is a flexible tube.12. The endoscopic surgical instrument of claim 1, further comprising atleast one control member extending through the tube and connecting at aproximal end to the actuator and at a distal end to the end effector.13. The endoscopic surgical instrument of claim 1, wherein said malefastener part includes a base and a shaft pivotally connected to thebase.
 14. The endoscopic surgical instrument of claim 13, wherein theshaft is pivotally connected to the base by a hinge.
 15. The endoscopicsurgical instrument of claim 13, wherein said shaft is configured tomove between a first position in which the shaft is positioned insubstantially the same plane as the base and a second position in whichthe shaft is positioned substantially perpendicular to said base.
 16. Anendoscopic surgical instrument for deploying a two part fastener havinga male fastener part and a female fastener part, comprising: a tubehaving a proximal end and a distal end; an end effector coupled to saiddistal end of said tube, said end effector configured to hold the malefastener part and the female fastener part in opposed relation; anactuator coupled to said proximal end of said tube and configured toactuate the end effector; and a shearing device proximate said endeffector and configured to shear off a tip of said male fastener partafter the male and female fastener parts are moved into a lockingrelation, said male fastner part including a base and a shaft pivotallyconnected to the base.
 17. The endoscopic surgical instrument of claim16, wherein the shaft is pivotally connected to the base by a hinge. 18.The endoscopic surgical instrument of claim 16, wherein said shaft isconfigured to move between a first position in which the shaft ispositioned in substantially the same plane as the base and a secondposition in which the shaft is positioned substantially perpendicular tosaid base.
 19. An endoscopic surgical instrument for deploying a twopart fastener having a male fastener part and a female fastener part,comprising: a flexible tube having a proximal end and a distal end; anend effector coupled to said distal end of said tube, said end effectorconfigured to hold the male fastener part and the female fastener partin opposed relation, the male fastener part including a shaft having aplurality of detent positions; and an actuator coupled to said proximalend of said tube and said actuator configured to actuate the endeffector, said tube defining a channel into which an endoscope may beinserted.
 20. The endoscopic surgical instrument of claim 19, whereinthe female fastener part is capable of resting in a locking relation ateach of said detent positions.
 21. The endoscopic surgical instrument ofclaim 19, wherein said male fastener part includes a base and a shaftpivotally connected to the base.
 22. The endoscopic surgical instrumentof claim 21, wherein the shaft is pivotally connected to the base by ahinge.
 23. The endoscopic surgical instrument of claim 21, wherein saidshaft is configured to move between a first position in which the shaftis positioned in substantially the same plane as the base and a secondposition in which the shaft is positioned substantially perpendicular tosaid base.
 24. An endoscopic surgical instrument for deploying a twopart fastener having a male fastener part and a female fastener part,comprising: a tube having a proximal end and a distal end; an endeffector coupled to said distal end of said tube, said end effectorconfigured to hold the male fastener part and the female fastener partin opposed relation, the male fastener part including a base and a shaftpivotally connected to the base, the shaft having a plurality of detentpositions; and an actuator coupled to said proximal end of said tube andsaid actuator configured to actuate the end effector.
 25. The endoscopicsurgical instrument of claim 24, wherein the shaft is pivotallyconnected to the base by a hinge.
 26. The endoscopic surgical instrumentof claim 24, wherein said shaft is configured to move between a firstposition in which the shaft is positioned in substantially the sameplane as the base and a second position in which the shaft is positionedsubstantially perpendicular to said base.
 27. An endoscopic surgicalinstrument for deploying a two part fastener having a male fastener partand a female fastener part, comprising: a tube having a proximal end anda distal end; an end effector coupled to said distal end of said tube,said end effector configured to hold the male fastener part and thefemale fastener part in opposed relation, said male fastener partincluding a base and a shaft pivotally connected to the base; and anactuator coupled to said proximal end of said tube and said actuatorconfigured to actuate the end effector.
 28. The endoscopic surgicalinstrument of claim 27, wherein the shaft is pivotally connected to thebase by a hinge.
 29. The endoscopic surgical instrument of claim 28,wherein said shaft is configured to move between a first position inwhich the shaft is positioned in substantially the same plane as thebase and a second position in which the shaft is positionedsubstantially perpendicular to said base.
 30. An endoscopic surgicalinstrument for deploying a two part fastener having a male fastener partand a female fastener part, comprising: a tube having a proximal end anda distal end; an end effector coupled to said distal end of said tube,said end effector configured to hold the male fastener part and thefemale fastener part in opposed relation, wherein said male fastenerpart includes a base and a shaft pivotally connected to the base, theshaft having a plurality of detent positions; an actuator coupled tosaid proximal end of said tube and said actuator configured to actuatethe end effector; and a shearing device proximate said end effector andconfigured to shear off a tip of said male fastener part after the maleand female fastener parts are moved into a locking relation.
 31. Theendoscopic surgical instrument of claim 30, wherein said female fastenerpart is capable of resting in said locking relation at each of saiddetent positions.
 32. The endoscopic surgical instrument of claim 30,wherein the shaft is pivotally connected to the base by a hinge.
 33. Theendoscopic surgical instrument of claim 32, wherein said shaft isconfigured to move between a first position in which the shaft ispositioned in substantially the same plane as the base and a secondposition in which the shaft is positioned substantially perpendicular tosaid base.